Corticotropin

NDA 10831, held by Organics Lagrange. Corticotropin.

As of Nov 13, 2026, NDA 10831 (Corticotropin), held by Organics Lagrange, was first approved by FDA on Sep 12, 1957, with 16 approved supplements and 0 published complete response letters.

First approved: Sep 12, 1957
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below


Dec 1, 1980	Supplement 49Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 1, 1980	Supplement 48Efficacy (new indication or use) · Standard review	Approved	None posted
Sep 12, 1957	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Corticotropin40 UNITS/ML · injectable;injection	Corticotropin	Discontinued
Corticotropin80 UNITS/ML · injectable;injection	Corticotropin	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Jul 14, 1992	Supplement 54Manufacturing · Standard review	Approved	None posted
Aug 30, 1989	Supplement 53Manufacturing · Standard review	Approved	None posted
Apr 28, 1988	Supplement 52Labeling · Standard review	Approved	None posted
Jan 9, 1985	Supplement 51Labeling · Standard review	Approved	None posted
Dec 1, 1980	Supplement 49Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 1, 1980	Supplement 48Efficacy (new indication or use) · Standard review	Approved	None posted
Feb 17, 1978	Supplement 40Manufacturing · Standard review	Approved	None posted
Aug 17, 1977	Supplement 43Labeling · Standard review	Approved	None posted
Aug 17, 1977	Supplement 42Labeling · Standard review	Approved	None posted
Feb 9, 1977	Supplement 39Labeling · Standard review	Approved	None posted
Aug 5, 1976	Supplement 38Manufacturing · Standard review	Approved	None posted
Jun 29, 1976	Supplement 37Labeling · Standard review	Approved	None posted
Jun 29, 1976	Supplement 36Labeling · Standard review	Approved	None posted
May 3, 1976	Supplement 35Labeling · Standard review	Approved	None posted
Dec 31, 1975	Supplement 34Labeling · Standard review	Approved	None posted
Dec 31, 1975	Supplement 32Labeling · Standard review	Approved	None posted
Sep 12, 1957	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 10831
Drugs@FDA: Overview at FDA
Company: Organics LaGrange

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters